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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 073209
Company: RISING

Products on ANDA 073209

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	EQ 5MG ANHYDROUS;50MG	TABLET;ORAL	Prescription	AB	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 073209

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/1991	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/20/2020	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
01/19/2012	SUPPL-22	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/14/2003	SUPPL-8	Labeling		Label is not available on this site.
09/18/2002	SUPPL-7	Labeling		Label is not available on this site.
08/28/2000	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
05/01/2000	SUPPL-5	Manufacturing (CMC)-Control		Label is not available on this site.
02/05/1998	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/15/1998	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
05/18/1993	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 073209

AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

TABLET;ORAL; EQ 5MG ANHYDROUS;50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	EQ 5MG ANHYDROUS;50MG	TABLET;ORAL	Prescription	No	AB	071111	BARR
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE	AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE	EQ 5MG ANHYDROUS;50MG	TABLET;ORAL	Prescription	No	AB	073209	RISING

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